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EXJADE Has an Established Safety Profile in Children and Adults1

Adverse reactions are ranked below using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Blood and lymphatic system disorders
Not known: Pancytopenia*, thrombocytopenia*, anaemia aggravated*, neutropenia
Immune system disorders
Not known: Hypersensitivity reactions (including anaphylaxis and angioedema)*
Metabolism and nutrition disorders
Not known: Metabolic acidosis
Psychiatric disorders
Uncommon: Anxiety, sleep disorder
Nervous system disorders
Common: Headache
Uncommon: Dizziness
Eye disorders
Uncommon: Early cataract, maculopathy
Rare: Optic neuritis
Ear and labyrinth disorders
Uncommon: Hearing loss
Respiratory, thoracic and mediastinal disorders
Uncommon: Pharyngolaryngeal pain
Gastrointestinal disorders
Common: Diarrhea, constipation, vomiting, nausea, abdominal pain, abdominal distension, dyspepsia
Uncommon: Gastrointestinal hemorrhage, gastric ulcer (including multiple ulcers), duodenal ulcer, gastritis
Rare: Esophagitis
Not known: Gastrointestinal perforation
Hepatobiliary disorders
Common: Transaminases increased
Uncommon: Hepatitis, cholelithiasis
Not known: Hepatic failure*
Skin and subcutaneous tissue disorders
Common: Rash, pruritus
Uncommon: Pigmentation disorder
Not known: Stevens-Johnson syndrome*, leukocytoclastic vasculitis*, urticaria*, erythema multiforme*, alopecia*
Renal and urinary disorders
Very common: Blood creatinine increased
Common: Proteinuria
Uncommon: Renal tubulopathy (acquired Fanconi's syndrome), glycosuria
Not known: Acute renal failure*; tubulointerstitial nephritis*, nephrolithiasis, renal tubular necrosis*
General disorders and administration site conditions
Uncommon: Pyrexia, edema, fatigue
* Adverse reactions reported during postmarketing experience. These are derived from spontaneous reports for which it is not always possible to reliably establish frequency or a causal relationship to exposure to the medicinal product.

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Gallstones and related biliary disorders were reported in about 2% of patients. Elevations of liver transaminases were reported as an adverse reaction in 2% of patients. Elevations of transaminases greater than 10 times the upper limit of the normal range, suggestive of hepatitis, were uncommon (0.3%). During postmarketing experience, hepatic failure, sometimes fatal, has been reported with EXJADE, especially in patients with pre-existing liver cirrhosis. There have been post-marketing reports of metabolic acidosis. The majority of these patients had renal impairment, renal tubulopathy (Fanconi's syndrome) or diarrhoea, or conditions where acid-base imbalance is a known complication. Serious acute pancreatitis may potentially occur as a complication of gallstones (and related biliary disorders). As with other iron chelator treatment, high-frequency hearing loss and lenticular opacities (early cataracts) have been uncommonly observed in patients treated with EXJADE.

Upper gastrointestinal ulceration and haemorrhage have been reported in patients, including children and adolescents, receiving EXJADE. Multiple ulcers have been observed in some patients. There have been reports of ulcers complicated with digestive perforation. Also, there have been reports of fatal gastrointestinal haemorrhages, especially in elderly patients who had haematological malignancies and/or low platelet counts. Physicians and patients should remain alert for signs and symptoms of gastrointestinal ulceration and haemorrhage during EXJADE therapy and promptly initiate additional evaluation and treatment if a serious gastrointestinal adverse reaction is suspected. Caution should be exercised in patients who are taking EXJADE in combination with substances that have known ulcerogenic potential, such as NSAIDs, corticosteroids, or oral bisphosphonates, in patients receiving anticoagulants and in patients with platelet counts below 50,000/mm3 (50 x 109/l).

Pediatric population

  • Diarrhea is reported more commonly in paediatric patients aged 2 to 5 years than in older patients.
  • Renal tubulopathy has been mainly reported in children and adolescents with β-thalassemia treated with EXJADE.

Managing the most common adverse events

Gastrointestinal event management from published key thought-leaders2, 3
ADVERSE EVENT Management Strategy
Abdominal pain
  • Patient should sip water and avoid solid food for several hours
  • Patient should avoid narcotic pain and nonsteroidal anti-inflammatory medications
  • Consider altering time of day of EXJADE administration
Mild-moderate diarrhea, nausea/vomiting
  • Ensure patient is adequately hydrated and avoid dairy products
  • Avoid solid foods until vomiting has stopped for at least 6 hours
  • If necessary, consider reducing dose to 10 mg/kg/day and titrate in weekly 5-mg/kg/day increments after resolution to return to previous dose
  • Transient, generally resolve without treatment discontinuation

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Adverse event management from the Summary of Product Characteristics1
ADVERSE EVENT Management Strategy
Skin rash
  • The rashes resolve spontaneously in most cases
  • When interruption of treatment may be necessary, treatment may be reintroduced after resolution of the rash, at a lower dose followed by gradual dose escalation
  • In severe cases this reintroduction could be conducted in combination with a short period of oral steroid administration
  • If SJS or any other severe skin reaction is suspected, EXJADE should be discontinued immediately and should not be reintroduced
Serum creatinine increases
  • For adult patients, the daily dose may be reduced by 10 mg/kg if a rise in serum creatinine by >33% above the average of the pre-treatment measurements and estimated creatinine clearance decreases below the lower limit of the normal range (<90 mL/min) are seen at two consecutive visits, and cannot be attributed to other causes
  • For pediatric patients, the dose may be reduced by 10 mg/kg if estimated creatinine clearance decreases below the lower limit of the normal range (<90 mL/min) and/or serum creatinine levels rise above the age-appropriate upper limit of normal at two consecutive visits
Serum Transaminases and Proteinuria Increases
  • If there is a persistent and progressive increase in serum transaminase levels that cannot be attributed to other causes, EXJADE should be interrupted.
  • Once the cause of the liver function test abnormalities has been clarified or after return to normal levels, cautious re-initiation of treatment at a lower dose followed by gradual dose escalation may be considered.

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β-thalassemia, MDS,
and SCD.